Status:
TERMINATED
Omnifit Hydroxylapatite (HA) Hip Outcomes Study
Lead Sponsor:
Stryker Orthopaedics
Conditions:
Arthroplasty, Replacement, Hip
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study was to obtain up to 25 year post-operative data on the Omnifit Hydroxylapatite (HA) Hip System in support of the hypothesis that it is a satisfactory system for reducing impl...
Eligibility Criteria
Inclusion
- For use as a universal hip replacement:
- Acute femoral neck fracture.
- Non-union of femoral head and neck fractures.
- Aseptic necrosis of the femoral head.
- Osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
- Salvage of failed total hip arthroplasty.
- For use as a total hip replacement:
- Severely disabled joints resulting from painful osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis.
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other procedure.
Exclusion
- Active infection in or near the hip joint.
- Pathological bone conditions which would significantly compromise the ability to carry physiologic stress levels and for which bone grafting would be inappropriate (i.e. severe osteoporosis, Paget's Disease, renal osteodystrophy, etc.).
- Neuro-muscular disorders in which the potentially adverse effects on prosthesis function are not outweighed by the benefits to be gained by the patient from usage of the implant.
- Mental disorders which would compromise essential patient post-operative care.
- Skeletal immaturity.
- Extreme obesity.
- Significant probability that patient could not return for required follow-up evaluations.
Key Trial Info
Start Date :
October 1 1987
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT00958347
Start Date
October 1 1987
End Date
May 1 2011
Last Update
August 19 2014
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
2
Hospital for Joint Disease/ Orthopaedic Institute
New York, New York, United States, 10128
3
Sewickley Valley Hospital
Moon Township, Pennsylvania, United States, 15108-4305
4
Trialbureau Orthopedics
Maastricht, Netherlands, 6202